BiomX has dosed the first subject in the randomised Phase IIb trial of the company’s fixed multi-phage therapy, BX004, to treat cystic fibrosis (CF).
This trial focuses on CF patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa).
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With topline outcomes anticipated in the first quarter of 2026, BX004 is expected to become a phage-based therapy for these life-threatening infections.
The double-blind, placebo-controlled trial aims to enrol approximately 60 CF subjects with chronic P. aeruginosa infections.
Subjects will be randomised in a 2:1 ratio and given either the therapy or a placebo through inhalation two times a day for eight weeks.
The study’s design includes a range of efficacy endpoints, such as a reduction in bacterial burden, lung function improvement, and quality of life improvements, as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Chronic Respiratory Infection Symptom Score (CRISS).
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By GlobalDataBuilding on the Phase Ib/IIa outcomes, the therapy claims to have shown potential in targeting and destroying P. aeruginosa, which traditional treatments have not been able to eliminate.
BiomX revealed encouraging results from Part 1 of the Phase Ib/IIa trial in February 2023, which demonstrated the tolerability, safety, and microbiologic activity of the therapy.
In the same year, the company completed dosing CF subjects in Part II of the Phase Ib/IIa trial.
BiomX CEO Jonathan Solomon said: “We’re seeing tremendous enthusiasm from both patients and investigators based on our encouraging Phase Ib/IIa results, in which 14.3% of patients cleared infections completely after ten days of treatment. Notably, this included individuals who had been living with chronic infections for over a decade, making these outcomes particularly meaningful and rarely seen in this population.
“In the second half of 2025, we anticipate feedback from the FDA regarding our plans on the analyses of real-world evidence to link bacterial reduction to clinical outcomes. Regulatory alignment on a microbiological endpoint would streamline the approval pathway and provide a means of addressing these patients with urgent unmet needs.”
The US Food and Drug Administration has already granted orphan drug and fast track designations to BX004.
